Study to Evaluate Safety, Tolerance and Efficacy of ASC22 Combined With ART in Subjects With HIV

HIV Infections Clinical Trial

Official title:

A Phase II Multi-center, Randomized,Blind, Placebo-controlled Study to Evaluate Safety,Tolerance and Efficacy of ASC22 Combined With ART in Subjects With Human Immunodeficiency Virus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05330143
• Other study ID #: ASC22-204
• Status: Recruiting
• Phase: Phase 2
• Start date: June 28, 2022
• Est. completion date: December 6, 2023

Study information

• Verified date: February 2023
• Source: Ascletis Pharmaceuticals Co., Ltd.
• Contact: Fusheng Wang, M.D
• Phone: 86-010-66933114
• Email: fswang302[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a phase II, multicenter, randomized, blind, placebo-controlled to evaluate the safety, tolerance, efficacy of ASC22 injection in combination with anti-retroviral therapy to treat subjects living with human immunodeficiency virus type 1.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 6, 2023
• Est. primary completion date: December 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age =18 and = 75 years old at screening.

• Treated with anti-retroviral medicine continuously for at least 12 months within 6 months of diagnosis of HIV-1 infection.

• Treated with anti-retroviral medicine continuously, contain integrase inhibitor, for at least months before screening.

• CD4+ Cell count =300 cells/µL and CD4+/ CD8+ratio = 0.9 at screening.

• Weight = 50 kg at screening.

Exclusion Criteria:

• Known allergy to the drug or excipients used in this trial.

• HIV-associated opportunistic infections in the past 5 years.

• Co-sensors of HBV, HCV, syphilis, etc.

• With bleeding disorders or on anticoagulant therapy.

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• HIV-1-infection
• Infections
• PD-L1 Gene Mutation

Intervention

Drug:
• ASC22 1mg/kg
ASC22 single-dose of 1mg/kg vials administered subcutaneously once 4 week.
• ASC22 2.5mg/kg
ASC22 single-dose of 2.5mg/kg vials administered subcutaneously once 4 week.
• Antiretroviral Therapy
standard antiretroviral therapy including Integrase inhibitors (INSTIs)
• Placebo
0.9% saline vials administered subcutaneously once 4 week.

Locations

Country	Name	City	State
China	The FifthMedical Center of the General Hospital of thePeoples Liberation Army	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Ascletis Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD4/CD8 ratio changes compared with baseline		Week 4\Week 8\Week 12
Secondary	HIV-DNA copy changes compared with baselnie		Week 12
Secondary	CD4+ count changes compared with baseline		Week 12
Secondary	CD8+ count changes compared with baseline		Week 12
Secondary	HLA-DR number changes compared with baseline		Week 12
Secondary	CD38 count changes compared with baseline		Week 12
Secondary	IL-2 concentration changes compared with baseline		Week 4\Week 8\Week 12